Quality Engineer — New Programs & Compliance

Mack Molding Company; Arlington (VT); On-site; USD 65,000 - 90,000; Full time

Job summary

Mack Molding Company is seeking a Quality Engineer to provide quality engineering support during new business development, program launches and ongoing customer programs.

You will draft Quality Plans, support FMEA and metrology requirements, and ensure compliance with ISO 13485 and 21 CFR Part 820. The role requires collaboration with program teams and continuous quality improvement across the product lifecycle.

Qualifications

• Drafts program Quality Plan and metrology labor plan to meet customer requirements.
• Prepares FMEA and DVQRs as needed.
• Prepares Certificates of Conformance (CoC) for outgoing products.
• Reviews program drawings/specifications to understand program requirements.
• Attends program team meetings to address quality-related matters.

Responsibilities

• Support new business development relating to quality matters as needed.
• Provides cost and time estimates for quality department services such as metrology or validation services.
• Ensures First Article Inspection (FAI) and capability studies are planned and completed.
• Manages Quality System Documentation including audits and regulatory compliance.
• Supports QBRs with customer and presents quality-related topics.
• Performs root cause analysis and corrective actions for quality issues.

Skills

Quality engineering

FMEA

Statistical methods

ISO 13485

21CFR Part 820

Documentation

Education

Bachelor's degree in Engineering

Five years related experience

AA/AS in technical field

Job description

Mack Molding Company is seeking a Quality Engineer to provide quality engineering support during new business development, program launches and ongoing customer programs.

You will draft Quality Plans, support FMEA and metrology requirements, and ensure compliance with ISO 13485 and 21 CFR Part 820. The role requires collaboration with program teams and continuous quality improvement across the product lifecycle.